ID

35849

Beschreibung

Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02474641

Link

https://clinicaltrials.gov/show/NCT02474641

Stichworte

Versionen (1)
  1. 27.03.19 27.03.19 -
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See clinicaltrials.gov

Hochgeladen am

27. März 2019

DOI

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Eligibility Early-Stage Breast Carcinoma NCT02474641

Englisch

Eligibility Early-Stage Breast Carcinoma NCT02474641

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, her-2/neu status upa/pai-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
Beschreibung

Breast Carcinoma | Breast-Conserving Surgery | Negative Surgical Margin | Independent of Risk factors Additional | Lymph node Status Positive | Lymph node Status Negative High risk | Estrogen Receptor Status | Progesterone Receptor Status | HER2/Neu Status | Urokinase Plasminogen Activator Inhibitor 1 Criteria | Systemic therapy Postoperative | Chemotherapy | Hormone Therapy | Antibody therapy | Diphosphonates

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0917927
UMLS CUI [3]
C1709157
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0035648
UMLS CUI [4,3]
C1524062
UMLS CUI [5,1]
C0024204
UMLS CUI [5,2]
C0449438
UMLS CUI [5,3]
C1514241
UMLS CUI [6,1]
C0024204
UMLS CUI [6,2]
C0449438
UMLS CUI [6,3]
C1513916
UMLS CUI [6,4]
C4319571
UMLS CUI [7,1]
C0034804
UMLS CUI [7,2]
C0449438
UMLS CUI [8]
C1514471
UMLS CUI [9]
C1512413
UMLS CUI [10,1]
C0042071
UMLS CUI [10,2]
C0030190
UMLS CUI [10,3]
C0243161
UMLS CUI [11,1]
C1515119
UMLS CUI [11,2]
C0032790
UMLS CUI [12]
C0392920
UMLS CUI [13]
C0279025
UMLS CUI [14]
C0281176
UMLS CUI [15]
C0012544
indication to adjuvant radiotherapy including boost radiotherapy
Beschreibung

Indication Adjuvant Radiotherapy | Indication Boost radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0242939
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C2919491
clearly identified primary tumor region preferably by radiopaque clips
Beschreibung

Primary tumor region Identified | Markers, Radiopaque

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C0205396
UMLS CUI [2]
C0181739
primary wound healing after breast conserving therapy without signs of infection
Beschreibung

Wound Healing Post Breast conserving therapy | Signs Absent Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043240
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0024885
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0009450
age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog ≤ 2 performance status
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
compliance regarding treatment appointments and toxicity
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
linguistic and cognitive ability to understand the questionnaires
Beschreibung

Language comprehension Questionnaires | Comprehension Questionnaires

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0034394
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0034394
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients operated by mastectomy
Beschreibung

Mastectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0024881
no indication for boost radiation (e.g. status after iort)
Beschreibung

Indication Boost radiation therapy | Status post Intraoperative radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2919491
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0338240
double sided breast cancer
Beschreibung

Bilateral breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0281267
resection margins positive for disease or insufficient identification of the boost volume
Beschreibung

Surgical margins Positive Disease | Boost Volume Identification Insufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229985
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C2919491
UMLS CUI [2,2]
C0449468
UMLS CUI [2,3]
C0205396
UMLS CUI [2,4]
C0231180
indication for radiotherapy of the regional lymph nodes
Beschreibung

Indication Therapeutic radiology procedure Regional lymph nodes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1179441
history of prior breast or thoracic radiotherapy
Beschreibung

Radiotherapy to breast Previous | Radiotherapy to thorax Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948310
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C4038705
UMLS CUI [2,2]
C0205156
extended postoperative seroma at the beginning of radiotherapy
Beschreibung

Postoperative seroma Extended

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998103
UMLS CUI [1,2]
C0231449
previously administered radiotherapy not allowing the required dose
Beschreibung

Therapeutic radiology procedure Previous | Dose Required Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0332268
pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
Beschreibung

Treatment Cancer Other | Study Subject Participation Status | Testing Therapeutic radiology procedure | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C0039593
UMLS CUI [3,2]
C1522449
UMLS CUI [4]
C0013230
patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
Beschreibung

Disease Adverse effects Treatment Compliance | Physical illness Serious Uncontrolled | Cerebrovascular Disorders Serious Uncontrolled | Myocardial Infarction | Nervous system disorder | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C4319828
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0007820
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0004936
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Ähnliche Modelle

Eligibility Early-Stage Breast Carcinoma NCT02474641

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Breast-Conserving Surgery | Negative Surgical Margin | Independent of Risk factors Additional | Lymph node Status Positive | Lymph node Status Negative High risk | Estrogen Receptor Status | Progesterone Receptor Status | HER2/Neu Status | Urokinase Plasminogen Activator Inhibitor 1 Criteria | Systemic therapy Postoperative | Chemotherapy | Hormone Therapy | Antibody therapy | Diphosphonates
Item
histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, her-2/neu status upa/pai-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
boolean
C0678222 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
C1709157 (UMLS CUI [3])
C0332291 (UMLS CUI [4,1])
C0035648 (UMLS CUI [4,2])
C1524062 (UMLS CUI [4,3])
C0024204 (UMLS CUI [5,1])
C0449438 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
C0024204 (UMLS CUI [6,1])
C0449438 (UMLS CUI [6,2])
C1513916 (UMLS CUI [6,3])
C4319571 (UMLS CUI [6,4])
C0034804 (UMLS CUI [7,1])
C0449438 (UMLS CUI [7,2])
C1514471 (UMLS CUI [8])
C1512413 (UMLS CUI [9])
C0042071 (UMLS CUI [10,1])
C0030190 (UMLS CUI [10,2])
C0243161 (UMLS CUI [10,3])
C1515119 (UMLS CUI [11,1])
C0032790 (UMLS CUI [11,2])
C0392920 (UMLS CUI [12])
C0279025 (UMLS CUI [13])
C0281176 (UMLS CUI [14])
C0012544 (UMLS CUI [15])
Indication Adjuvant Radiotherapy | Indication Boost radiation therapy
Item
indication to adjuvant radiotherapy including boost radiotherapy
boolean
C3146298 (UMLS CUI [1,1])
C0242939 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C2919491 (UMLS CUI [2,2])
Primary tumor region Identified | Markers, Radiopaque
Item
clearly identified primary tumor region preferably by radiopaque clips
boolean
C0677930 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,3])
C0181739 (UMLS CUI [2])
Wound Healing Post Breast conserving therapy | Signs Absent Communicable Disease
Item
primary wound healing after breast conserving therapy without signs of infection
boolean
C0043240 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0024885 (UMLS CUI [1,3])
C0311392 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog ≤ 2 performance status
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
compliance regarding treatment appointments and toxicity
boolean
C0525058 (UMLS CUI [1])
Language comprehension Questionnaires | Comprehension Questionnaires
Item
linguistic and cognitive ability to understand the questionnaires
boolean
C0233733 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Mastectomy
Item
patients operated by mastectomy
boolean
C0024881 (UMLS CUI [1])
Indication Boost radiation therapy | Status post Intraoperative radiation therapy
Item
no indication for boost radiation (e.g. status after iort)
boolean
C3146298 (UMLS CUI [1,1])
C2919491 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0338240 (UMLS CUI [2,2])
Bilateral breast cancer
Item
double sided breast cancer
boolean
C0281267 (UMLS CUI [1])
Surgical margins Positive Disease | Boost Volume Identification Insufficient
Item
resection margins positive for disease or insufficient identification of the boost volume
boolean
C0229985 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2919491 (UMLS CUI [2,1])
C0449468 (UMLS CUI [2,2])
C0205396 (UMLS CUI [2,3])
C0231180 (UMLS CUI [2,4])
Indication Therapeutic radiology procedure Regional lymph nodes
Item
indication for radiotherapy of the regional lymph nodes
boolean
C3146298 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1179441 (UMLS CUI [1,3])
Radiotherapy to breast Previous | Radiotherapy to thorax Previous
Item
history of prior breast or thoracic radiotherapy
boolean
C0948310 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C4038705 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Postoperative seroma Extended
Item
extended postoperative seroma at the beginning of radiotherapy
boolean
C1998103 (UMLS CUI [1,1])
C0231449 (UMLS CUI [1,2])
Therapeutic radiology procedure Previous | Dose Required Lacking
Item
previously administered radiotherapy not allowing the required dose
boolean
C1522449 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Treatment Cancer Other | Study Subject Participation Status | Testing Therapeutic radiology procedure | Investigational New Drugs
Item
treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0039593 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4])
Disease Adverse effects Treatment Compliance | Physical illness Serious Uncontrolled | Cerebrovascular Disorders Serious Uncontrolled | Myocardial Infarction | Nervous system disorder | Mental disorders
Item
patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
boolean
C0012634 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C0683323 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0007820 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
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